Quality Assurance Supervisor

Job Description

Job Description

Quality Assurance Supervisor – DHR Review

• Onsite position in Roseville, CA - Relocation support provided if required
• Medical Device Organization seeking QA Supervisor to oversee DHR Reviewers for life saving products.
• Leadership experience is required and knowledge of Device History Records or Batch Records

Job Description

The QA Supervisor – DHR Review plays a pivotal role in maintaining the integrity and effectiveness of the Quality System by overseeing Device History Record (DHR) review activities and leading the team of DHR Reviewers. This position supervises daily operations, drives process improvements, and ensures compliance with applicable medical device regulations while supporting internal stakeholders and regulatory audits.

Responsibilities

• Supervise and oversee DHR Review areas within the Quality System, ensuring consistent, compliant, and timely review of Device History Records.
• Select, manage, train, and develop staff, fostering a high-performing team culture focused on quality, accuracy, and continuous improvement.
• Establish clear objectives and assignments for team members and provide ongoing feedback through performance reviews and individual development plans.
• Manage the scheduling of DHR Reviewers to ensure appropriate coverage, prioritization, and balanced workload across all review activities.
• Coordinate with internal customers to establish prioritizations, resolve discrepancies, and support cross-functional collaboration.
• Communicate process changes to internal customers and provide training to ensure proper understanding and adoption of updated procedures.
• Perform DHR reviews personally when needed to support throughput, quality, and team workload.
• Analyze and generate trending data related to DHR and Quality System performance to monitor effectiveness and identify opportunities for improvement.
• Evaluate procedures and work instructions to identify processing improvements and implement changes as necessary to enhance efficiency and compliance.
• Support Quality System processes during internal and external regulatory audits by providing documentation, explanations, and evidence of compliance.
• Proactively seek system improvements while maintaining strict adherence to applicable medical device regulations and quality requirements.
• Communicate Quality System issues to upper management in a clear, solution-oriented manner, presenting recommendations and action plans as appropriate.
• Ensure a high degree of accuracy and attention to detail in all DHR and quality-related activities.
• Prioritize and manage multiple assignments simultaneously, maintaining strong organizational control over team tasks and deadlines.

Job Type & Location

This is a Permanent position based out of Roseville, CA.

The pay range for this position is $70000.00 - $100000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Healthcare packagedesigns, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need

This is a fully onsite position in Roseville,CA.

This position is anticipated to close on Sep 4, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.